Evidence-based planning of a randomized controlled trial on diaphragm use for prevention of sexually transmitted infections

Sexually Transmitted Diseases

Volumn 35, Issue 3, 2008, Pages 238-242

  Behets, Frieda M T F ^a,b   Van Damme, Kathleen ^b,c   Turner, Abigail Norris ^a   Rabenja, Ny Lovaniaina ^c   Ravelomanana, Noro L R ^c   Raharinivo, Mbolatiana S M ^c   Zeller, Kimberly A ^d   Rennie, Stuart M ^b,e   Swezey, Teri A ^a  

^a IL   (United States)

^b UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

^c UNC MAD   (Madagascar)

^d BROWN UNIVERSITY   (United States)

^e UNIVERSITY OF NORTH CAROLINA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; ARTICLE; CLINICAL RESEARCH; CONDOM; CONTROLLED STUDY; EVIDENCE BASED PRACTICE; FEMALE; FOLLOW UP; HUMAN; HYGIENE; INFECTION PREVENTION; INFORMATION PROCESSING; INTERVIEW; MAJOR CLINICAL STUDY; PREGNANCY; SEXUAL BEHAVIOR; SEXUALLY TRANSMITTED DISEASE; UTERINE CERVIX CAP;

ADOLESCENT; ADULT; CONTRACEPTIVE DEVICES, FEMALE; EVIDENCE-BASED MEDICINE; FEMALE; FOCUS GROUPS; HUMANS; HYGIENE; MADAGASCAR; MIDDLE AGED; PATIENT ACCEPTANCE OF HEALTH CARE; PILOT PROJECTS; POVERTY; PROSPECTIVE STUDIES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SEXUALLY TRANSMITTED DISEASES; WOMEN'S HEALTH;

EID: 42949110996     PISSN: 01485717     EISSN: None     Source Type: Journal    
DOI: 10.1097/OLQ.0b013e31815abaa2     Document Type: Article

References (61)

1. Cohen MS. Sexually transmitted diseases enhance HIV transmission: No longer a hypothesis. Lancet 1998; 351(suppl 3):5-7.
2. Corbett EL, Steketee RW, ter Kuile FO, et al. HIV-1/AIDS and the control of other infectious diseases in Africa. Lancet 2002; 359:2177-2187.
3. Fleming DT, Wasserheit JN. From epidemiological synergy to public health policy and practice: The contribution of other sexually transmitted diseases to sexual transmission of HIV infection. Sex Transm Infect 1999; 75:3-17.
4. Orner P, Harries J, Cooper D, et al. Challenges to microbicide introduction in South Africa. Soc Sci Med 2006; 63:968-978.
5. Minnis AM, Padian NS. Choice of female-controlled barrier methods among young women and their male sexual partners. Fam Plann Perspect 2001; 33:28-34.
6. Moench TR, Chipato T, Padian NS. Preventing disease by protecting the cervix: The unexplored promise of internal vaginal barrier devices. AIDS 2001; 15:1595-1602.
7. Kelaghan J, Rubin GL, Ory HW, et al. Barrier-method contraceptives and pelvic inflammatory disease. JAMA 1982; 248:184-187.
8. Wolner-Hanssen P, Eschenbach DA, Paavonen J, et al. Decreased risk of symptomatic chlamydial pelvic inflammatory disease associated with oral contraceptive use. JAMA 1990; 263:54-59.
9. Cramer DW, Goldman MB, Schiff I, et al. The relationship of tubal infertility to barrier method and oral contraceptive use. JAMA 1987; 257:2446-2450.
10. Becker TM, Wheeler CM, McGough NS, et al. Contraceptive and reproductive risks for cervical dysplasia in southwestern Hispanic and non-Hispanic white women. Int J Epidemiol 1994; 23:913-922.
11. Hildesheim A, Brinton LA, Mallin K, et al. Barrier and spermicidal contraceptive methods and risk of invasive cervical cancer. Epidemiology 1990; 1:266-272.
12. Wright NH, Vessey MP, Kenward B, et al. Neoplasia and dysplasia of the cervix uteri and contraception: A possible protective effect of the diaphragm. Br J Cancer 1978; 38:273-279.
13. Magder LS, Harrison HR, Ehret JM, et al. Factors related to genital Chlamydia trachomatis and its diagnosis by culture in a sexually transmitted disease clinic. Am J Epidemiol 1988; 128:298-308.
14. Rosenberg MJ, Davidson AJ, Chen JH, et al. Barrier contraceptives and sexually transmitted diseases in women: A comparison of female-dependent methods and condoms. Am J Public Health 1992; 82:669-674.
15. Austin H, Louv WC, Alexander WJ. A case-control study of spermicides and gonorrhea. JAMA 1984; 251:2822-2824.
16. Bradbeer CS, Thin RN, Tan T, et al. Prophylaxis against infection in Singaporean prostitutes. Genitourin Med 1988; 64:52-53.
17. Minnis AM, Padian NS. Effectiveness of female controlled barrier methods in preventing sexually transmitted infections and HIV: Current evidence and future research directions. Sex Transm Infect 2005; 81:193-200.
18. Behets FM, Rasolofomanana JR, Van Damme K, et al. Evidence-based treatment guidelines for sexually transmitted infections developed with and for female sex workers. Trop Med Int Health 2003; 8:251-258.
19. Behets FM, Van Damme K, Rasamindrakotroka A, et al. Sociodemographic and behavioural factors associated with high incidence of sexually transmitted infections in female sex workers in Madagascar following presumptive therapy. Sex Health 2005; 2:77-84.
20. Power R. The application of qualitative research methods to the study of sexually transmitted infections. Sex Transm Infect 2002; 78:87-89.
21. Behets F, Norris Turner A, Van Damme K, et al. Acceptability and feasibility of continuous diaphragm use among sex workers in Madagascar. Sex Transm Infect 2005; 81:472-476.
22. Rekart ML. Sex-work harm reduction. Lancet 2005; 366:2123-2134.
23. Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: Recommendations for good practice. J Eval Clin Pract 2004; 10:307-312.
24. Malterud K. The art and science of clinical knowledge: Evidence beyond measures and numbers. Lancet 2001; 358:397-400.
25. Kitzinger J. Qualitative research. Introducing focus groups. BMJ 1995; 311:299-302.
26. Morgan DL. Focus groups. Annu Rev Sociol 1996; 22:129-152.
27. VanLandingham M, Knodel J, Saengtienchai C, et al. Aren't sexual issues supposed to be sensitive? Health Transit Rev 1994; 4:85-90.
28. Hart GJ, Pool R, Green G, et al. Women's attitudes to condoms and female-controlled means of protection against HIV and STDs in south-western Uganda. AIDS Care 1999; 11:687-698.
29. Bender DE, Ewbank D. The focus group as a tool for health research: Issues in design and analysis. Health Transit Rev 1994; 4:63-80.
30. Rakotonanahary A, Rafransoa Z, Bensaid K. Qualitative evaluation of HIV/AIDS IEC activities in Madagascar. Eval Program Plann 2002; 25:341-345.
31. Bentley ME, Fullem AM, Tolley EE, et al. Acceptability of a microbicide among women and their partners in a 4-country phase I trial. Am J Public Health 2004; 94:1159-1164.
32. Coggins C, Blanchard K, Friedland B. Men's attitudes towards a potential vaginal microbicide in Zimbabwe, Mexico and the USA. Reprod Health Matters 2000; 8:132-141.
33. Feldblum PJ, Bwayo JJ, Kuyoh M, et al. The female condom and STDs: Design of a community intervention trial. Ann Epidemiol 2000; 10:339-346.
34. Green G, Pool R, Harrison S, et al. Female control of sexuality: Illusion or reality? Use of vaginal products in south west Uganda. Soc Sci Med 2001; 52:585-598.
35. Mantell JE, Morar NS, Myer L, et al. "We have our protector": Misperceptions of protection against HIV among participants in a microbicide efficacy trial. Am J Public Health 2006; 96:1073-1077.
36. Mason TH, Foster SE, Finlinson HA, et al. Perspectives related to the potential use of vaginal microbicides among drug-involved women: Focus groups in three cities in the United States and Puerto Rico. AIDS Behav 2003; 7:339-351.
37. Morrow K, Rosen R, Richter L, et al. The acceptability of an investigational vaginal microbicide, PRO 2000 Gel, among women in a phase I clinical trial. J Womens Health (Larchmt) 2003; 12:655-666.
38. Pool R, Whitworth JA, Green G, et al. An acceptability study of female-controlled methods of protection against HIV and STDs in south-western Uganda. Int J STD AIDS 2000; 11:162-167.
39. van de Wijgert JHHM, Khumalo-Sakutukwa GM, Coggins C, et al. Men's attitudes toward vaginal microbicides and microbicide trials in Zimbabwee. Int Fam Plan Perspect 1999; 25:15-20.
40. Weeks MR, Mosack KE, Abbott M, et al. Microbicide acceptability among high-risk urban U.S. women: Experiences and perceptions of sexually transmitted HIV prevention. Sex Transm Dis 2004; 31:682-690.
41. Pool R. Acceptability of the female condom and vaginal spermicidal products in Uganda. Sex Health Exch 1999; 1:5-7.
42. Veldhuijzen N, Nyinawabega J, Umulisa M, et al. Preparing for microbicide trials in Rwanda: Focus group discussions with Rwandan women and men. Cult Health Sex 2006; 8:395-406.
43. Bulut A, Ortayli N, Ringheim K, et al. Assessing the acceptability, service delivery requirements, and use-effectiveness of the diaphragm in Colombia, Philippines, and Turkey. Contraception 2001; 63:267-275.
44. Bernard HR. Social Research Methods. Thousand Oaks, CA: Sage Publications, 2000.
45. Miles MB, Huberman AM. Qualitative Data Analysis: An Expanded Sourcebook, 2nd ed. Thousand Oaks, CA: Sage Publications, 1994.
46. Mays N, Pope C. Rigour and qualitative research. BMJ 1995; 311:109-112.
47. Patton MQ. Enhancing the quality and credibility of qualitative analysis. Health Serv Res 1999; 34(5, Part 2):1189-1208.
48. Agar M. Toward a qualitative epidemiology. Qual Health Res 2003; 13:974-986.
49. Leutscher PD, Behets F, Rousset D, et al. Sexual behavior and sexually transmitted infections in men living in rural Madagascar: Implications for HIV transmission. Sex Transm Dis 2003; 30:262-265.
50. Zeller HG, Ramamonjisoa A, Boisier P, et al. HIV infection in Madagascar in 1995. AIDS 1997; 11:401-402.
51. Feldblum PJ, Hatzell T, Van Damme K, et al. Results of a randomised trial of male condom promotion among Madagascar sex workers. Sex Transm Infect 2005; 81:166-173.
52. Behets F, Andriamiadana J, Rasamilalao D, et al. Sexually transmitted infections and associated socio-demographic and behavioural factors in women seeking primary care suggest Madagascar's vulnerability to rapid HIV spread. Trop Med Int Health 2001; 6:202-211.
53. Severy LJ, Tolley E, Woodsong C, et al. A framework for examining the sustained acceptability of microbicides. AIDS Behav 2005; 9:121-131.
54. Severy LJ, Newcomer S. Critical issues in contraceptive and STI acceptability research. J Soc Issues 2005; 61:45-65.
55. Malterud K. Qualitative research: Standards, challenges, and guidelines. Lancet 2001; 358:483-488.
56. Campbell R, Quilty B, Dieppe P. Discrepancies between patients' assessments of outcome: Qualitative study nested within a randomised controlled trial. BMJ 2003; 326:252-253.
57. Schumacher KL, Koresawa S, West C, et al. Qualitative research contribution to a randomized clinical trial. Res Nurs Health 2005; 28:268-280.
58. Donovan J, Mills N, Smith M, et al. Quality improvement report: Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. Commentary: Presenting unbiased information to patients can be difficult. BMJ 2002; 325:766-770.
59. Creswell JW, Fetters MD, Ivankova NV. Designing a mixed methods study in primary care. Ann Fam Med 2004; 2:7-12.
60. McKibbon KA, Gadd CS. A quantitative analysis of qualitative studies in clinical journals for the 2000 publishing year. BMC Med Inform Decis Mak 2004; 4:11.
61. Sandelowski M. Using qualitative research. Qual Health Res 2004; 14:1366-1386.